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Help Control Drug Costs and Developing World Access by Contacting the Senate in time for TOMORROW’s Likely Vote!

Submitted by WPimport on Tue, 07/14/2009 - 00:30
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As early as TOMORROW (Tuesday), the Senate Health, Education, Labor and Pensions (HELP) Committee will decide how much additional monopoly to give to biologic drugs -- those engineered from living cells such as cancer treatments and vaccines -- as part of the health care reform package. Specifically, supported by the American Association of Universities, major research universities in the U.S. and Canada, they are considering a proposal that would grant biologic drugs an unprecedented total of 13.5 years of data exclusivity, a monopoly period that would delay the introduction of price-lowering generic competition for crucial life-saving treatments for illnesses like cancer, arthritis and diabetes as well as vaccines. This will keep medicine prices high and out of the hands of many consumers in the U.S. and in developing countries.

What can you do?
Luckily, Senator Sherrod Brown (D-OH) has proposed a much better alternative for consumers. Senator Brown is proposing an amendment that suggests a much more reasonable and generous compromise of seven (7) years exclusivity for brand-name biologics.

We need your help to change this. Will you call and/or email the senators on the HELP committee today and ask them to support Senator Brown’s seven year proposal, or any other proposal that may be put forward that offers the lowest amount of exclusivity possible? [Scroll to the bottom for contact information and a script]

The Issue

This 13.5 year data exclusivity period is about twice the length of time proposed by the White House and more than twice the length that is given to traditional chemical drugs under the 1984 Hatch-Waxman Act, which regulates other types of generics. The White House is offering what it calls a “generous compromise” of seven (7) years and brand-name conventional drugs are given a minimum of five (5) years data exclusivity (plus extensions) under the 1984 Hatch-Waxman Act. The brand-name pharmaceutical and biotech industry, supported by the American Association of Universities, has been aggressively lobbying Congress for an FDA approval pathway for generic biologics (also called biosimilars, biogenerics or follow-on biologics) that gives them a minimum of 14 years of data exclusivity.

What is data exclusivity?
When a generic company seeks approval for a generic drug, it shows that its product is the same as, or essentially similar to, a brand-name product. It then relies on, but does not repeat, the full battery clinical tests performed by the brand-name maker. Data exclusivity prohibits the generic firm from relying on the brand-name test data, effectively barring the generic from the market for a set period of time. It gives the brand-name firm a monopoly on selling that product, a monopoly separate and distinct from the patent monopolies already attached to these products, and which will not be disturbed by the legislation.

Why is data exclusivity a danger?
Data exclusivity can delay the introduction of price-lowering generic drug competition -- keeping prices high longer -- for drugs that are not able to obtain patent protection, or for which the patent term has already expired. A Federal Trade Commission study [i] among others, have also shown that 13 years of data exclusivity is NOT necessary for PhRMA to make huge profits.

Important biologics include several of the most important drugs used during chemotherapy, for the treatment of severe arthritis and psoriasis and very importantly, vaccines. Biologic drugs are the fastest growing segment of the pharmaceutical market, and they are priced significantly higher on average than brand-name conventional drugs. In some cases, prices approach or exceed $100,000 per patient, per year. Biologics priced at tens of thousands of dollars per patient per year are commonplace. For example, the top-selling biologic Enbrel, Pfizer/Amgen's arthritis treatment, costs $15-20,000 per patient per year. Roche-Genentech's breast cancer drug Avastin costs approximately $185,00 per year.

What can you do?
Luckily, Senator Sherrod Brown (D-OH) has proposed a much better alternative for consumers. Senator Brown is proposing an amendment that suggests a much more reasonable and generous compromise of seven (7) years exclusivity for brand-name biologics.

But we need your help to make this happen. Will you call and/or email the senators on the HELP committee TUESDAY and ask them to support Senator Brown’s seven year proposal, or any other proposal that may be put forward that offers the lowest amount of exclusivity possible?

It is extremely urgent as Congress is unpredictable. The decision could be finalized as early as TUESDAY! Please call or email some senators.

Following is a list of key Senators on the HELP Committee with contact information (staff name, email and office telephone #), a sample phone script, and a sample email script should you prefer that. Please choose a senator from your state, if possible, and if there isn’t one included, choose one or more from the lists below

The key senators to target are

Top Priority:
Senator Jack Reed (RI) (202) 224-4642 Topher Spiro topher_spiro@reed.senate.gov
Senator Patty Murray (WA) (202) 224-2621 Paula Burg Paula_Burg@murray.senate.gov
Senator Barbara Mikulski (MD) (202) 224-4654 Peter Rubin Peter_Rubin@help.senate.gov
Senator Kay Hagan (NC) (202) 224-6342

Second Priority:
Bob Casey Jr. (PA) (202) 224-6324 Morna_Murray@casey.senate.gov
Chris Dodd (CT) 202-224-2823 Tamar Magarik-Haro tamar_magarikharo@help.senate.gov
Tom Harkin (IA) 202-224-3254 Jenelle Krishnamoorthy jenelle_krishnamoorthy@harkin.gov
Jeff Merkley(OR) (202)224-3753 Susan_Lexer@merkley.senate.gov

Third Priority
Jeff Bingaman (NM) (202) 224-5521 Fred Isasi Frederick_isasi@bingaman.senate.gov
Ted Kennedy (MA) 202-224-7675 Tom Kraus Tom_Kraus@help.senate.gov

Phone Script (What to say whether you reach a staff person or are sent to voicemail)

1. Identify yourself and then tell him or her you would like to leave a brief message for the Senator, such as: "Please tell Senator xxx that I would like him/her to support Senator Brown’s proposal for seven years data exclusivity for biologic drugs when they vote this week on the biogenerics (or follow-on biologics) issue.”

2. You may also want to briefly state reasons for your support. It is best that you all state your reasons in your own words. If you all say exactly the same thing, it is not as powerful.

One idea is to say something like I support Senator Brown’s proposal because:
- Data exclusivity can delay the introduction of price-lowering generic drug competition, keeping prices high beyond the patent expiration date. Please support the lowest-possible data exclusivity period for life-saving biologics.
- Biologics cost much more than conventional drugs but studies show they cost the same to develop. Please make sure consumers don’t pay too heavy a price and wait far too long for life-saving cancer and arthritis drugs.

3. If you reach him or her personally, let them know you will be following up (and then do so). You may also request a written response to your telephone call if you like. If you get his voicemail, give him your email address and phone number so he or she can respond to you, and let him know you will follow-up.

Whether or not you reach the person, you may also want to send a follow-up email, using the sample email below.

Sample email

Dear Senator or Staff person [insert name],

I'm writing to strongly urge you to support Senator Sherrod Brown’s compromise proposal regarding follow-on biologic drugs, which would give brand-name drug makers a minimum of seven (7) years of data exclusivity.

Biologics are very expensive medicines which include cancer treatments, vaccines and a variety of other interventions, many of which costs tens of thousands of dollars per patient, per year. Current prices threaten to further cripple our health care system.

As you know, traditional chemical drugs received a minimum of five (5) years of data exclusivity under the 1984 Hatch-Waxman Act, which I believe should be the same for biologics. The brand-name industry is seeking fourteen years of protection for biologics. The Federal Trade Commission recently found that a fourteen year-period would be excessive and unnecessary to induce further biomedical innovation. [i] The Obama Administration has signaled that it supports a “generous compromise” of seven (7) years.

At a time when we are seeing the cost of our health care growing out of control, when 60% of bankruptcies are related to health care costs, [ii] please demonstrate your commitment to American consumers by ensuring lower-cost generic medicines to consumers while continuing to provide incentives for innovation. We believe that Senator Brown’s seven (7) year proposal will best do this and we ask you to support its adoption into current health care reform legislation.

Thank you for your consideration. I'll look forward to your response and am happy to speak further about this issue with you or a member of your staff.

Kind Regards,

NAME, AFFILIATION (e.g. Universities Allied for Essential Medicines or American Medical Student Association and your University) , your ADDRESS (VERY IMPORTANT TO INCLUDE YOUR ADDRESS IF YOU HAVE AN ADDRESS IN THE SENATOR’S HOME STATE )

Notes
i See Federal Trade Commission, Emerging Health Care Issues: Follow-On Biologic Drug Competition, June 2009. Available at: http://www.ftc.gov/opa/2009/06/biologics.shtm and Henry Grabowski, Outlook: Follow-on biologics: data exclusivity and the balance between innovation and competition. Nature Reviews Drug Discovery 7, 479-488 (June 2008). Available at: http://www.nature.com/nrd/journal/v7/n6/full/nrd2532.html.

ii Arnst, Catherine. “Study Links Medical Cost and Personal Bankruptcy.” BusinessWeek June 4, 2009. Available at: http://www.businessweek.com/bwdaily/dnflash/content/jun2009/db2009064_666715.htm.